NCI sponsors Canadian cold/flu remedy trial in leukemia patients

Cancer patients, with their weakened immune systems, are particularly vulnerable when the cold and flu season hits. The National Cancer Institute (NCI), part of the National Institutes of Health and the world's most prestigious cancer research body, is sponsoring a landmark trial to evaluate if a unique Canadian cold remedy - ginseng extract COLD-FX - can help.

The trial, involving chronic lymphocytic leukemia (CLL) patients, is the first time the natural medicine will be part of a clinical study associated with cancer. The trial will be conducted by cancer and infectious diseases experts at Wake Forest University School of Medicine.

The impetus for the COLD-FX trial came from two prominent researchers at Wake Forest University School of Medicine: Principal Investigator Kevin High, M.D., Chief of Infectious Diseases and Professor of Medicine in the sections on Infectious Diseases, Hematology and Oncology, and Molecular Medicine, and Director of the General Clinical Research Center (GCRC), and Edward Shaw, M.D., Principal Investigator of Wake Forest's Community Clinical Oncology Program Research Base. They will coordinate a broad network of cancer specialists involved in the study.

The double-blind, placebo-controlled trial, involving more than 300 patients, was originally planned to include up to 100 U.S. research sites. However, in approving the study, the NCI accelerated the process - targeting completion over a single cold and flu season. To assist in recruitment, it also opened up its cancer trials support unit network of more than 1,500 cancer research sites across the United States.

"CLL is a common and chronic condition that primarily afflicts older adults, those age 60 and over. The risk of respiratory infections is greatly enhanced in CLL patients because of immune dysfunction that accompanies the disease and is worsened by current treatments," said High. The weakened immune system means vaccines don't work as well in CLL patients so alternate means of preventing infection are an urgent need. In the U.S., the Healthcare Cost and Utilization Project reported that hospital costs for chronic lymphocytic leukemia patients alone amounted to $125 million in 2000.

"Our hypothesis - that COLD-FX could reduce infections by enhancing immune function in CLL patients - is supported by previous research," said High. "This includes encouraging results from studies that importantly included older adults, even studies that demonstrated safety and effectiveness in seniors in nursing homes, conducted by Dr. Janet McElhaney, an influenza expert and Division Head, Geriatric Medicine at the University of British Columbia and Providence Health Care." Analogous to CLL patients, residents of nursing homes often have multiple chronic conditions and are at high risk for respiratory infection.

Promising research also has been done by cancer researcher Dr. Sandra Miller of the Department of Anatomy and Biology in the Faculty of Medicine of Montreal's McGill University. The Canadian National Research Council sponsored study showed that COLD-FX administered to mice with leukemia helped return their immune systems to normal levels and improved their lifespans significantly."

Participants will take 400 milligrams of COLD-FX per day or a placebo over the 2008/2009 cold and flu season. The trial will examine COLD-FX's effectiveness in preventing acute respiratory infections and its overall safety during the three-month period from January to April 2009. The researchers will also study antibiotic utilization, the duration and severity of acute respiratory infections, all other incidences of infection, chronic lymphocytic leukemia disease activity, and parameters related to immune health.

"COLD-FX stimulates anti-cancer and ant-viral immunity in mice. It is therefore an excellent candidate for testing in human patients. It is very different from other ginseng-derived products and is uniquely comprised of a single active class of molecules extracted from the plant: a specific type of polysaccharides," Dr. Miller said.

The Comprehensive Cancer Center at Wake Forest University is currently conducting approximately 150 cancer trials and is regarded as one of America's leading cancer research facilities according to an annual ranking conducted by U.S. News and World Report and the NCI.